Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study.
Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study.
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DOI：
10.1136/annrheumdis-2015-208562
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发表时间：
2016-11
影响因子：
27.4
通讯作者：
CD1067 study investigators
中科院分区：
文献类型：
--
作者：
Khamashta M;Merrill JT;Werth VP;Furie R;Kalunian K;Illei GG;Drappa J;Wang L;Greth W;CD1067 study investigators
在一项在中重度活动性系统性红斑狼疮（SLE）成人患者中开展的IIb期、随机、双盲、安慰剂对照研究（NCT 01283139）中评估了西伐单抗的疗效和安全性。431例患者接受随机分组，除标准治疗药物外，每月静脉注射西法木单抗（200 mg、600 mg或1200 mg）或安慰剂。 患者根据疾病活动性、干扰素基因签名测试（基于四种基因表达的高与低）和地理区域进行分层。主要疗效终点为第52周达到SLE应答者指数应答的患者百分比。与安慰剂相比，接受西法木单抗（所有剂量）的患者达到主要终点的百分比更高（安慰剂：45.4%; 200 mg：58.3%; 600 mg：56.5%; 1200 mg：59.8%）。 其他改善包括皮肤红斑狼疮疾病面积和严重程度指数评分（每月200 mg和1200 mg）、医生总体评估（每月600 mg和1200 mg）、基于不列颠群岛狼疮评估组的综合狼疮评估（每月1200 mg）、SLE疾病活动指数-2000评分降低4分以及肿胀关节和压痛关节计数减少。 安慰剂组17.6%的患者和西法木单抗组18.3%的患者发生严重不良事件。西伐单抗治疗组带状疱疹感染更常见。Sifalimumab是一种很有前途的成人SLE治疗方法。改善在各种临床终点中是一致的，包括疾病活动的总体和器官特异性指标。NCT 01283139;结果。
The efficacy and safety of sifalimumab were assessed in a phase IIb, randomised, double-blind, placebo-controlled study (NCT01283139) of adults with moderate to severe active systemic lupus erythematosus (SLE). 431 patients were randomised and received monthly intravenous sifalimumab (200 mg, 600 mg or 1200 mg) or placebo in addition to standard-of-care medications. Patients were stratified by disease activity, interferon gene-signature test (high vs low based on the expression of four genes) and geographical region. The primary efficacy end point was the percentage of patients achieving an SLE responder index response at week 52. Compared with placebo, a greater percentage of patients who received sifalimumab (all dosages) met the primary end point (placebo: 45.4%; 200 mg: 58.3%; 600 mg: 56.5%; 1200 mg 59.8%). Other improvements were seen in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (200 mg and 1200 mg monthly), Physician's Global Assessment (600 mg and 1200 mg monthly), British Isles Lupus Assessment Group-based Composite Lupus Assessment (1200 mg monthly), 4-point reductions in the SLE Disease Activity Index−2000 score and reductions in counts of swollen joints and tender joints. Serious adverse events occurred in 17.6% of patients on placebo and 18.3% of patients on sifalimumab. Herpes zoster infections were more frequent with sifalimumab treatment. Sifalimumab is a promising treatment for adults with SLE. Improvement was consistent across various clinical end points, including global and organ-specific measures of disease activity. NCT01283139; Results.
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影响因子：
13.3
作者：
Chiche, Laurent;Jourde-Chiche, Noemie;Whalen, Elizabeth;Presnell, Scott;Gersuk, Vivian;Dang, Kristen;Anguiano, Esperanza;Quinn, Charlie;Burtey, Stephane;Berland, Yvon;Kaplanski, Gilles;Harle, Jean-Robert;Pascual, Virginia;Chaussabel, Damien
通讯作者：
Chaussabel, Damien
影响因子：
2.6
作者：
Obermoser G;Pascual V
通讯作者：
Pascual V
影响因子：
--
作者：
Petri, Michelle;Wallace, Daniel J.;Spindler, Alberto;Chindalore, Vishala;Kalunian, Kenneth;Mysler, Eduardo;Neuwelt, C. Michael;Robbie, Gabriel;White, Wendy I.;Higgs, Brandon W.;Yao, Yihong;Wang, Liangwei;Ethgen, Dominique;Greth, Warren
通讯作者：
Greth, Warren
影响因子：
3.9
作者：
Abeler-Doerner, Lucie;Rieger, Cosima C.;Kuhn, Annegret
通讯作者：
Kuhn, Annegret
影响因子：
4.9
作者：
Rönnblom L;Alm GV
通讯作者：
Alm GV